WO2021162508A1 - Boîtier supérieur comprenant une unité de régulation de débit, et kit de diagnostic sur site le comprenant - Google Patents

Boîtier supérieur comprenant une unité de régulation de débit, et kit de diagnostic sur site le comprenant Download PDF

Info

Publication number
WO2021162508A1
WO2021162508A1 PCT/KR2021/001882 KR2021001882W WO2021162508A1 WO 2021162508 A1 WO2021162508 A1 WO 2021162508A1 KR 2021001882 W KR2021001882 W KR 2021001882W WO 2021162508 A1 WO2021162508 A1 WO 2021162508A1
Authority
WO
WIPO (PCT)
Prior art keywords
flow rate
rate control
control unit
sample
pad
Prior art date
Application number
PCT/KR2021/001882
Other languages
English (en)
Korean (ko)
Inventor
이정훈
김강현
이준우
Original Assignee
광운대학교 산학협력단
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 광운대학교 산학협력단 filed Critical 광운대학교 산학협력단
Publication of WO2021162508A1 publication Critical patent/WO2021162508A1/fr

Links

Images

Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366—Apparatus specially adapted for solid-phase testing
    • G01N33/54386—Analytical elements
    • G01N33/54387—Immunochromatographic test strips
    • G01N33/54388—Immunochromatographic test strips based on lateral flow
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5023—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures with a sample being transported to, and subsequently stored in an absorbent for analysis
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/5302—Apparatus specially adapted for immunological test procedures
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/06—Auxiliary integrated devices, integrated components
    • B01L2300/0627—Sensor or part of a sensor is integrated
    • B01L2300/0645—Electrodes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0809—Geometry, shape and general structure rectangular shaped
    • B01L2300/0825—Test strips
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/16—Surface properties and coatings
    • B01L2300/161—Control and use of surface tension forces, e.g. hydrophobic, hydrophilic
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00—Moving or stopping fluids
    • B01L2400/08—Regulating or influencing the flow resistance
    • B01L2400/084—Passive control of flow resistance
    • B01L2400/086—Passive control of flow resistance using baffles or other fixed flow obstructions

Definitions

  • the present invention relates to an upper case capable of controlling a flow rate, and a field diagnostic kit having the same, and more particularly, to a field diagnostic kit prepared to enable control of a flow rate of a sample.
  • the diagnostic kit enables testing of various diseases by using antigen-antibody reactions, and can test trace amounts of analytes in various fields such as agriculture, livestock industry, military, and environment as well as medical testing for various diseases.
  • the conventional diagnostic kit for the field mainly controls the flow rate through the formation of a micro/nano flow rate regulator on paper through a lateral flow type immune sensor (LFA), and improves the sensitivity.
  • a flow rate control unit was formed using a wax pattern, a polydimethylsiloxane (PDMS) pattern, etc. on paper.
  • the limit of detection (LOD) is improved by about 3 times by a wax pattern or a polydimethylsiloxane (PDMS) pattern, and the flow rate can be controlled using a wax pattern.
  • the diagnostic kit using the wax pattern formed on the paper is a method that maximizes the reaction as the flow rate is reduced as the fluid is disturbed. If not, there is a problem that the flow rate cannot be reduced.
  • the present invention includes at least one flow rate control unit on the inside of the upper case coupled to the lower case, and includes an analysis strip attached to the lower case, and applies pressure to the analysis strip through one or more flow rate control units.
  • the purpose is to maximize the reaction speed and accuracy of the reaction result by controlling the
  • a diagnostic kit provides an upper case including an injection unit into which a sample to be analyzed is introduced, and one or more flow rate controllers for adjusting the flow rate of the input to be analyzed.
  • a lower case provided to be assembled corresponding to the upper case and an analysis strip attached to the lower case and displaying a reaction result according to the diffusion of the sample to be analyzed in a state at least partially pressurized by the flow rate control unit do.
  • the at least one flow rate control unit includes a hydrophobic coating layer formed by the hydrophobic coating and a hydrophilic coating layer formed by the hydrophilic coating, and the sample to be analyzed avoids the flow rate control unit including the hydrophobic coating layer to control the flow rate including the hydrophilic coating layer It is characterized in that it is temporarily concentrated or mixed by moving in the direction in which the sub is located.
  • the hydrophobic coating is implemented through at least one of a plasma treatment method, a hydrophobic silane coating method, or a Teflon coating method through a gas forming a hydrophobic gas
  • the hydrophilic coating is plasma treatment through a gas forming a hydrophilic gas It is characterized in that it is implemented through at least one of a method or a hydrophilic silane coating method.
  • the one or more flow rate control unit includes a selective ion permeable membrane coating layer or an electrode coating layer formed of an electrode coated by a selective ion permeable membrane, and the selective ion permeable membrane coating layer is ion concentration polarized by an electric field (electric field) Concentration Polarization (ICP) phenomenon occurs, and the sample to be analyzed is concentrated without passing through the flow rate control unit including the ion permeable membrane coating layer in a state in which the electric field is applied, and flows as it moves in a state in which the electric field is blocked It is characterized in that it is controlled.
  • ICP electric field Concentration Polarization
  • the analysis strip is bonded to a first pad to which the analysis target sample is absorbed, the first pad, and a second pad including a condensate reacting with the analysis target sample and the second pad, and a third pad forming a reaction unit for confirming a reaction result formed by the reaction of the sample to be analyzed and the condensate, and a control unit for confirming movement of the sample to be analyzed.
  • the analysis strip includes a pressing region representing a region to which the pressure is applied by contacting the flow rate control unit at an upper end, and the pressing region is the second pad, the third pad, or the second pad and the third pad. It is characterized in that it is formed in at least one of between.
  • the pressure applied to the pressurized region is controlled by the height of the one or more flow rate controllers, and the flow rate of the sample to be analyzed is controlled according to the height of the one or more flow rate controllers to control the reaction rate and accuracy of the reaction result characterized in that
  • the assay strip further includes a fourth pad in contact with the third pad and absorbing the sample to be analyzed remaining after passing through the third pad.
  • the upper case may include a plurality of section path regions in which the one or more flow rate adjusting units are disposed in a width direction, and the plurality of section path regions may include: a first section path region in which the one or more flow rate adjusting units are disposed; and a second section path area in which the one or more flow rate controllers are disposed so as not to overlap at least partially with the first section path area.
  • the flow rate control unit forms a plurality of nano-structured projections, the plurality of projections control the flow rate of the sample to be analyzed by an area in contact with the analysis strip and applied pressure, and the plurality of projections have a dome shape , a bump shape, a pillar shape, a triangular shape, characterized in that it is formed to include at least one of the chamber shape.
  • the upper case according to another embodiment of the present invention includes an injection unit forming a hole into which an analysis target sample is input, a test window for confirming a reaction result of the analysis target sample, and a flow rate of the input analysis target sample one or more flow rate regulators for
  • the one or more flow rate control unit forms a plurality of nano-structured projections, the plurality of projections control the flow rate of the sample to be analyzed by an area in contact with the analysis strip, and the plurality of projections have a dome shape, a bump It is characterized in that it is formed including at least one shape, a pillar shape, a triangular shape, and a chamber shape.
  • the at least one flow rate control unit includes a hydrophobic coating layer formed by the hydrophobic coating and a hydrophilic coating layer formed by the hydrophilic coating, and the sample to be analyzed avoids the flow rate control unit including the hydrophobic coating layer to control the flow rate including the hydrophilic coating layer It is characterized in that it is temporarily concentrated or mixed by moving in the direction in which the sub is located.
  • the flow rate control unit includes a selective ion permeable membrane coating layer and an electrode coating layer formed of an electrode coated by a selective ion permeable membrane, the selective ion permeable membrane coating layer is ion concentration polarization by an electric field (electric field) , ICP) phenomenon, and the sample to be analyzed is concentrated without passing through the flow rate control unit including the ion permeable membrane coating layer in a state where the electric field is applied, and the flow is controlled as the electric field is moved while the electric field is blocked characterized by being
  • one or more flow rate control units are included in the upper case of the diagnostic kit, and when pressure is applied to the analysis strip coupled to the lower case by one or more flow rate control units, the analysis target By controlling the flow rate of the sample, it is possible to increase the accuracy by reducing the reaction rate of the reaction result according to the reaction of the sample to be analyzed.
  • FIGS. 1 and 2 are diagrams illustrating a diagnostic kit according to an embodiment of the present invention.
  • FIG. 3 is a view showing the structure of the upper case of the diagnostic kit according to an embodiment of the present invention.
  • FIG. 4 is a view showing the shape of one or more flow rate control unit located in the upper case according to an embodiment of the present invention.
  • ICP ion Concentration Polarization
  • FIG. 6 is a view showing the shape and arrangement of the flow rate control unit according to an embodiment of the present invention.
  • FIG. 7 and 8 are diagrams illustrating a concentration plug by ion concentration polarization (ICP) according to an arrangement of a flow rate controller according to an embodiment of the present invention.
  • ICP ion concentration polarization
  • FIG. 9 is a view showing a shape in which the upper case according to an embodiment of the present invention is coupled to the lower case to which the analysis strip is attached.
  • FIG. 10 is a view showing a portion in contact with the analysis strip at least one flow rate control unit located in the upper case according to an embodiment of the present invention.
  • FIG. 11 is a view illustrating a flow rate control unit showing a hydrophobic or hydrophilic coating layer and a flow rate control unit coated with an ion exchange material according to an embodiment of the present invention.
  • FIG. 12 is a view showing one or more flow rate control unit treated with hydrophobic / hydrophilic according to an embodiment of the present invention.
  • FIG. 13 is a view showing one or more flow rate controllers coated with a selective ion exchange material according to an embodiment of the present invention.
  • 15 is a graph for observing the reaction results of the diagnostic kit according to the concentration in various embodiments of the present invention.
  • 16 is a diagram illustrating false positives of an influenza test (Influenza kit) according to the concentration of a surfactant in an embodiment of the present invention.
  • the present invention relates to an upper case having at least one flow rate control unit and a field diagnostic kit having the same.
  • FIGS. 1 and 2 are diagrams illustrating a diagnostic kit according to an embodiment of the present invention.
  • a diagnostic kit 10 includes an upper case 100 , a lower case 200 , and an analysis strip 300 .
  • the diagnostic kit 10 may omit some of the various components exemplarily illustrated in FIG. 1 or may additionally include other components.
  • the diagnostic kit 10 may control the reaction rate and accuracy by controlling the flow rate of the sample to be analyzed by one or more flow rate controllers formed inside the upper case 100 .
  • the reaction rate may refer to the rate at which the analysis target sample 312 diffuses and displays the reaction results on the reaction unit 332 and the control unit 334 of the third pad 330 . have.
  • the accuracy indicates the degree of accuracy of the reaction results displayed on the reaction unit 332 and the control unit 334 by the analysis target sample 312 .
  • the accuracy is higher as the speed of the sample to be analyzed 312 is lower.
  • the accuracy increases.
  • the upper case 100 may include one or more flow rate control units 110 to which the analysis target sample 312 is injected, and to adjust the flow rate of the input analysis target sample 312 .
  • the sample to be analyzed 312 is an antigen and refers to a substance or organism used for testing.
  • the sample to be analyzed 312 may be secretions such as blood, sweat, saliva, and urine, but is not limited thereto.
  • the one or more flow rate control units 110 may form a plurality of nano-structured protrusions.
  • the plurality of protrusions may control the flow rate of the analyte sample 312 by the area in contact with the analysis strip 300 and the applied pressure.
  • the plurality of protrusions may be formed to include at least one of a dome shape, a bump shape, a pillar shape, a triangular shape, and a chamber shape.
  • the upper case 100 includes a flow rate control unit 110 , an injection unit 120 , and a test window 130 .
  • the injection unit 120 is implemented on one side of the upper case 100 so that a sample to be analyzed 312 may be injected.
  • the injection unit 120 forms a hole through which the analyte sample 312 can be injected, and is connected around the hole and is implemented in the form of a hole and includes a fixing part to block the hole. (312) It is possible to prevent contact between the inside and the outside of the diagnostic kit 10 before injection.
  • the diagnostic kit 10 may include a flow rate control unit 110 around the injection unit 120 .
  • the flow rate control unit 110 is provided between the injection unit 120 and the test window 130 to control the flow rate of the sample to be analyzed 312 injected into the injection unit 120 to provide the test window 130 . It is possible to increase the accuracy of the resulting reaction results.
  • a plurality of flow rate control units 110 may be provided in the upper case 100 within a predetermined area.
  • the plurality of flow rate control units 110 may be formed at different intervals and sizes, respectively.
  • the flow rate control unit 110 includes a vertical interval (a) between each flow rate control unit 110 within a predetermined area, an interval from the flow rate control unit 110 to the end of the predetermined area (b), and a flow rate control unit 110 ) may be implemented in the upper case 100 by varying the horizontal spacing c between them.
  • the analysis strip 300 provided in the lower case 200 is implemented in 350um to 390um, so that the flow rate adjusting unit 110 of the upper case 100 increases the pressure inward by 280um to 320um. may be added, but is not necessarily limited thereto.
  • the upper case 100 will be described in detail with reference to FIG. 3 .
  • FIG. 3 is a view showing the structure of the upper case of the diagnostic kit according to an embodiment of the present invention.
  • the upper case 100 includes an injection unit 120 and a test window 130 , and one or more flow rate control units 110 are formed inside the upper case 100 .
  • the upper case 100 may omit some of the various components exemplarily illustrated in FIG. 3 or may additionally include other components.
  • the injection unit 120 may form a hole into which the analysis target sample 312 is injected.
  • the hole of the injection unit 120 is shown to be formed in a circular shape, but is not necessarily limited thereto, and may be formed in a polygonal shape.
  • the sample to be analyzed 312 may be injected into the first pad 310 through the hole of the injection unit 120 .
  • the injection unit 310 may be located at a position corresponding to the first pad 310 of the analysis strip 300 into which the analysis target sample 312 is absorbed.
  • the test window 130 may check a reaction result of the analysis target sample 312 .
  • the test window 130 may be located at a position corresponding to the third pad 330 of the analysis strip 300 displaying the reaction result.
  • reaction results are the reaction unit 332 and the control unit 334 , and are displayed so as to be visually confirmed.
  • Figure 3 (a) is a view showing a rectangular shape of the flow rate control unit of the upper case according to an embodiment of the present invention
  • Figure 3 (b) is a plurality of flow rate control of the upper case according to an embodiment of the present invention It is a view showing an additional zigzag shape
  • (c) of Fig. 3 is a view showing a V-shaped flow rate control unit of the upper case according to an embodiment of the present invention
  • Fig. 3 (d) is an embodiment of the present invention
  • the flow rate control unit 110 may be implemented inside the upper case 100 through processing or injection.
  • one or more flow rate control unit 110 may be formed in various shapes inside the upper case 100 , and the shape and number may be changed according to the flow rate to be controlled.
  • the one or more flow rate control unit 110 may be designed in various shapes, and may be implemented with an area and a height for controlling the flow rate in an optimal state.
  • the flow rate control unit 110 may be formed to a height of 0.01 mm to 20 mm, the upper case 100 and the lower case 200 are formed to be equal to or less than 1 mm in height in the combined form.
  • the diameter of the protrusion 111 included in the flow rate control unit 110 preferably has a height or a diameter of 10 ⁇ m to 100 ⁇ m.
  • the diameter of the flow rate control unit 110 may be formed in a size of 10 um to 10 mm.
  • the diameter of the flow rate control unit 110 when the diameter of the flow rate control unit 110 is formed to be smaller than 10 um, it may be broken when combined with the lower case 200 and applying pressure to the analysis strip 300 . .
  • the diameter of the flow rate control unit 110 is formed to be larger than 10 mm, the flow rate control unit 110 is coupled with the lower case 200 to increase the area to apply pressure to the analysis strip 300 , so the analysis target A problem that may limit the movement of the sample 312 may occur.
  • the flow rate control unit 110 applies a pressure higher than the standard to the analysis strip 300 , through which the analysis target sample 312 . As the flow rate of is slowed, a problem that cannot be analyzed may occur. When the height of the flow rate control unit 110 is formed to a size smaller than 0.01 mm, the flow rate control unit 110 applies a pressure lower than the standard to the analysis strip 300 , or a problem may occur in which the pressure cannot be applied. When the height of the flow rate adjusting unit 110 is greater than the height in the form in which the upper case 100 and the lower case 200 are combined, the upper case 100 is the lower case 200 by the flow rate adjusting unit 110 .
  • the flow rate control unit 110 cannot be combined with When the height of the flow rate control unit 110 is less than 1 mm in height in the form in which the upper case 100 and the lower case 200 are combined, the flow rate control unit 110 does not come into contact with the analysis strip 300 and , the problem of not being able to apply pressure may occur.
  • the flow rate control unit 110 further including the protrusion 111 applies more dense pressure to the analysis strip 300 through a thinner diameter and height than the flow rate control unit 110 that does not include the protrusion 111 to be analyzed.
  • the movement of the sample 312 may be controlled in detail.
  • the depth of the portion that enters the interface of the analysis strip 300 by the flow rate control unit 110 is 1 ⁇ m from the surface of the analysis strip 300 . It may be implemented to penetrate the thickness of the assay strip 300 .
  • the thickness of the analysis strip 300 may be implemented as 100 um to 200 um.
  • the portion into which the flow rate control unit 110 enters while pressing the analysis strip 300 represents a portion entered by the pressurization of the flow rate control unit 110 based on the thickness of the analysis strip 300 before pressing.
  • the height of the portion where the flow rate control unit 110 enters while pressing the analysis strip 300 is low, there may be a problem in that the movement of the analyte sample 312 cannot be restricted, and the flow rate is adjusted while pressing the analysis strip 300 If the height of the part into which the part 110 is inserted is high, it may interfere with the movement of the analysis target sample 312 , thereby causing a problem in which accuracy is lowered.
  • FIG. 4 is a view showing the shape of one or more flow rate control unit located in the upper case according to an embodiment of the present invention.
  • the flow rate controller 110 may form a plurality of nano-structured protrusions 111 .
  • Figure 4 (a) is a view showing a shape in which a plurality of circular projections 111 are attached to the semicircular flow rate control unit 110 according to an embodiment of the present invention
  • Figure 4 (b) is a view showing a shape in which a plurality of cylindrical protrusions 111 are attached to the cylindrical flow rate adjusting unit 110 according to an embodiment of the present invention
  • FIG. 4 (c) is an embodiment of the present invention. It is a view showing a shape in which a plurality of protrusions 111 in a circular shape are attached to the flow rate adjusting unit 110 in a cylindrical shape according to an example.
  • the one or more flow rate controller 110 may form a plurality of protrusions 111 , and may control the pressure and area applied to the analysis strip 300 by the plurality of protrusions 111 .
  • the one or more flow rate control unit 110 is illustrated as a plurality of protrusions 111 all forming the same shape, but is not necessarily limited thereto and a plurality of protrusions having different shapes.
  • 111 may be formed in the flow rate control unit 110 , or may be formed of a plurality of protrusions 111 having different shapes for each of one or more different flow rate control units 110 .
  • the upper case 100 and the lower case 200 may be replaced with plastics or polymers, and the like, but is not limited thereto, and a suitable material may be used according to the implemented design.
  • ICP ion Concentration Polarization
  • Figure 5 (a) is an exemplary view showing the inside of the upper case and the lower case of the diagnostic kit 10 according to an embodiment of the present invention
  • Figure 5 (b) is the movement of the sample to be analyzed by fluorescence (Fluorescence) ) is a diagram showing an image.
  • one or more flow rate control units 110 may be provided between the injection unit 120 of the upper case 100 and the test window 130 , and may be formed with a predetermined area and height.
  • the flow rate controller 110 may be implemented in a 3 X 5 array, but is not necessarily limited thereto.
  • FIG. 5 (b) shows a shape in which the sample to be analyzed 312 is moved by the plurality of flow rate controllers 110, and ion concentration polarization around the plurality of flow rate controllers 110 is polarized (Ion Concentration Polarization, ICP) phenomenon occurs.
  • ICP Ion Concentration Polarization
  • Nafion resin was coated on the plurality of flow rate controllers 110 of the upper case 100 to induce ion concentration polarization (ICP).
  • ICP ion concentration polarization
  • the ion concentration polarization phenomenon is a phenomenon in which a biological material having a specific charge is concentrated in a microfluid, and a biological material can be controlled using an electrical phenomenon of the fluid without chemical bonding and separation processes.
  • Materials for inducing ion concentration polarization include Nafion, polystyrene sulfonate (PSS), or polyallylamine hydrochloride (PAH), but is not necessarily limited thereto.
  • FIG. 6 is a view showing the shape and arrangement of the flow rate control unit according to an embodiment of the present invention.
  • the plurality of flow rate control units 110 may be provided within a predetermined area of the upper case 100 .
  • the predetermined area may represent a rectangle forming a horizontal X and a vertical Y, but is not necessarily limited thereto.
  • the one or more flow rate control units 110 may be implemented to be provided within a predetermined area of horizontal X and vertical Y, and all flow rate control units 110 of the same size and shape may be arranged at the same interval, and must It is not limited.
  • the upper case 100 may include one or more flow rate control units 110 , and may include a plurality of section path regions in which one or more flow rate control units 110 are disposed in the width direction.
  • the section path region is an area in which one or more flow rate control units are disposed in the width direction of the upper case 100 , and may be divided into a plurality of areas according to a shape in which the flow rate control units are disposed.
  • the plurality of section path regions may include a first section path region in which one or more flow rate controllers are disposed and a second section path region in which one or more flow rate controllers are disposed so as not to overlap at least partially with the first section path region.
  • the flow rate control unit may be provided in a zigzag for each section path region so that the sample to be analyzed flows uniformly.
  • the upper case 100 may include a pressing area in which one or more flow rate control units 110 are located at a position where the flow rate control unit 110 is provided, and an opening area in which the flow rate control unit 110 is not located.
  • the pressing region may include both a surface projected to the end portion of the flow rate control unit 110 pressing the analysis strip 300 and a portion fixed to the upper case 100 .
  • One or more flow rate control units formed in the upper case 100 may vary the size of the pressing region indicated by the area and length of the pressing region, and the adjacent spacing between the pressing regions provided at the closest positions among the pressing regions.
  • the adjacent interval may be divided into an interval between the flow rate controllers provided in the section path region and the interval between the flow rate controllers in the section path region.
  • One or more flow rate adjusting units 110 of #1 of FIG. 6 may be arranged in a 5 X 3 arrangement.
  • the section path region has 5 sections, and three flow rate control units are provided for each section, and each flow rate control unit forms an interval a with each other and has a diameter b in a circular shape. It may be implemented to be formed in the same way.
  • a represents the adjacent spacing
  • b represents the size of the pressing area.
  • One or more flow rate adjusting units 110 of #2 of FIG. 6 may be arranged in a 5 X 3 arrangement.
  • #2 of FIG. 6 there are 5 sections in the section path region, and three flow rate controllers may be provided for each section.
  • the vertical spacing of each flow rate controller forms an interval a, and it is implemented so that all of the diameters are the same as b in the form of a circle, and the horizontal intervals are formed with a spacing d from each other, so as to face the left end
  • the interval between the provided flow rate control units is formed at an interval c, and the interval between the flow rate control units provided to face the right end is formed at the interval e.
  • the plurality of flow rate control units in #2 may be implemented such that the interval a is wider than the plurality of flow rate control units in #1.
  • One or more flow rate regulators of #3 of FIG. 6 may be arranged in a 4 X 2 arrangement.
  • #3 of FIG. 6 there are four section path regions, and two flow rate control units may be provided for each section.
  • the vertical spacing of each flow rate controller is formed with an interval a, and it is implemented to have the same diameter as b in the form of a circle, and each horizontal interval is formed with an interval c to face the left end. It may be implemented such that the interval between the provided flow rate control units is formed at the interval c, and the interval between the flow rate control units provided to face the right end is formed at the interval c.
  • One or more flow rate control units of #4 of FIG. 6 are provided on the left and right sides in a triangular arrangement, respectively, are provided in a 3 X 2 X 1 arrangement from bottom to top on the left side, and 3 X 2 X 1 from top to bottom on the right side It may be provided in an array.
  • the section path region has two sections, and the flow rate controller may be arranged to have a triangular shape for each section.
  • the one or more flow rate control units are each implemented so as to have the same diameter as a in the form of a circle, each of the horizontal intervals is formed at a distance d from each other, and the interval between the flow rate control units provided to face the left end is the interval. It is formed with e and the interval c, and the interval between the flow rate control unit provided to face the right end may be implemented to be formed with the interval b and the interval c.
  • One or more flow rate control units 110 of #5 of FIG. 6 may be arranged to form a triangular shape on the left and an elliptical shape on the right.
  • the section path region has two sections, and may include a section in which two triangular-shaped flow speed controllers are provided and a section in which oval-shaped flow speed controllers are provided.
  • the flow rate control unit of the triangular shape on the upper and lower sides of the left side within a certain area in the upper case 100 is formed with a length of each side of d, forms an interval of b with each other, and is provided to face the left end of the flow rate
  • An interval between the adjusting units may be formed as an interval c.
  • the oval-shaped flow rate control unit on the right side may be formed with an interval a between the upper end and the lower end.
  • the plurality of flow rate control units 110 of #6 of FIG. 6 may be arranged in a 4 X 3 arrangement.
  • #6 of FIG. 6 there are four section path regions, and three flow rate control units may be provided for each section.
  • the interval a between each flow rate control unit is formed, and the diameter is b in a circular shape so that they are all the same. It may be implemented such that the interval is formed at the interval c, and the interval between the flow rate controller provided to face the right end is formed at the interval c.
  • the plurality of flow rate control units 110 may be provided in the upper case 100 by variously configuring the size, shape, arrangement, etc., and is not limited to a specific shape.
  • ICP ion concentration polarization
  • FIG. 7 and 8 are diagrams illustrating a concentration plug by ion concentration polarization (ICP) according to an arrangement of a flow rate controller according to an embodiment of the present invention.
  • ICP ion concentration polarization
  • ICP ion concentration polarization
  • ICP 7 is a concentration plug by ion concentration polarization (Ion Concentration Polarization, ICP) according to the shape in which the flow rate control unit 110 is arranged in 1 X 3, 2 X 3, 3 X 3, 4 X 3, 5 X 3, respectively.
  • ICP ion Concentration Polarization
  • the concentration plug flows uniformly through the analysis strip 300 by arranging the flow rate control unit 110 in a zigzag manner.
  • the flow rate control unit 110 moves along the analysis strip 300 according to the number and arrangement structure provided. Accordingly, in the diagnostic kit 10 , the arrangement structure and number of the flow rate controller 110 may be different according to the sample to be analyzed 312 injected.
  • the upper case 100 has a plurality of section path regions provided with one or more flow rate adjusting units, and the flow rate adjusting unit provided in the segment path region and the flow rate adjusting unit provided in the most adjacent section path region are at least partially shifted and overlapped. It may be provided not to. Accordingly, the concentration of the sample to be analyzed is uniformly made by preventing the flow rate adjusting unit provided in the section path region and the flow rate adjusting unit provided in the most adjacent section path region from being shifted and overlapping at least partially, and one or more flow rate adjusting units are provided The more the section path region is formed, the longer the concentration length of the sample to be analyzed may be.
  • the lower case 200 may be provided to be assembled to correspond to the upper case 100 .
  • the analysis strip 300 is attached to the lower case 200 , and may form a reaction result according to the reaction of the injected analysis target sample 312 .
  • the analysis strip 300 is attached to the lower case 200, is smaller than the lower case, and has a preset shape.
  • the preset shape may be formed in a rectangular shape, and a plurality of pads may be combined and implemented, but is not necessarily limited thereto.
  • the analysis strip 300 is a lateral flow analysis strip, and the injected analysis target sample 312 may be implemented to move left or right.
  • the assay strip 300 includes a first pad 310 , a second pad 320 , a third pad 330 , and a fourth pad 340 .
  • the analysis strip 300 may omit some components or additionally include other components among various components illustrated by way of example in FIG. 1 .
  • the first pad 310 may absorb the analysis target sample 312 .
  • the first pad 310 is a sample pad, and is a pad into which the analyte sample 312 to be detected is injected, but is not limited thereto.
  • the first pad 310 may absorb and diffuse the injected sample to be analyzed 312 .
  • the second pad 320 is in contact with the first pad 310 , and may include a condensate 322 reacting with the sample to be analyzed 312 .
  • the second pad 320 is a conjugation pad, and is a pad including a detector.
  • the detector may be a condensate 322 , and may bind to the analyte sample 312 .
  • the second pad 320 receives the sample to be analyzed 312 from the first pad 310 , and the sample to be analyzed 312 and the condensate 322 included in the second pad 320 are combined.
  • the third pad 330 is in contact with the second pad 320, and a reaction unit 332 and an analysis target sample ( A control unit 334 that confirms the movement of the 312 may be formed.
  • the third pad 330 is a test pad, and is a pad including a reaction unit 332 and a control unit 334 .
  • the reaction unit 332 may display whether an analyte is present in the analysis target sample 312
  • the control unit 334 may display whether the analysis target sample 312 moves.
  • the analyte may mean a disease or a virus, but is not necessarily limited thereto.
  • the third pad 330 receives the antigen-antibody conjugate in which the analyte sample 312 and the condensate 322 are bound from the second pad 320 , and the reaction unit 332 and the antigen-antibody conjugate may be combined and displayed as a line, and the control unit 334 and the analyte sample 312 may be combined and displayed as a line.
  • the contrast portion 334 is a line that is always displayed.
  • the diagnostic kit 10 may determine that the diagnostic kit 10 is defective when the analysis target sample 312 is injected but the control unit 334 is not displayed.
  • reaction unit 332 and the control unit 334 may be displayed as lines, but the present invention is not limited thereto. can be displayed so that
  • the analysis strip 300 may include a pressurizing region representing a portion to which one or more flow rate control units 110 abut and apply pressure at an upper end thereof.
  • the pressing region may be formed in at least one of the second pad 320 , the third pad 330 , or between the second pad 320 and the third pad 330 .
  • the pressure applied to the pressurized region is adjusted by the height of the one or more flow rate control units 110 , and the flow rate of the sample to be analyzed 312 is controlled according to the height of the one or more flow rate control units 110 to determine the reaction rate and You can control the accuracy.
  • the fourth pad 340 is in contact with the third pad 330 , and may absorb the analyte sample 312 remaining after passing through the third pad 330 .
  • the material absorbed by the fourth pad 340 is not limited to the sample to be analyzed 312 , and is passed through the antibody conjugate 322 positioned on the second pad 320 or the injection unit 110 of the upper case 100 . It may be a separate foreign material that is injected.
  • the fourth pad 340 is an absorbent pad, and the sample to be analyzed remaining after passing through the first pad 310 , the second pad 320 , and the third pad 330 . (312) can be absorbed.
  • a plurality of pads having different cross-sectional areas are overlapped, and the thickness of the plurality of pads or the number of the plurality of pads can be adjusted according to the amount of the sample to be analyzed, and must be
  • the present invention is not limited thereto.
  • the number of the plurality of pads constituting the analysis strip 300 and the spacing between the plurality of pads are not limited thereto, and various structural changes are possible according to the type of the analysis target sample to be analyzed.
  • FIG. 9 is a view showing a shape in which the upper case according to an embodiment of the present invention is coupled to the lower case to which the analysis strip is attached.
  • Figure 9 (a) is a view illustrating the coupling direction of the upper case, the lower case, and the analysis strip according to an embodiment of the present invention
  • Figure 9 (b) is an upper case according to an embodiment of the present invention
  • It is a diagram showing the shape in which the lower case and the analysis strip are combined.
  • the analysis strip 300 may be attached to the upper end of the lower case 200 .
  • the upper case 100 corresponds to the first pad 310 and the injection unit 120 of the analysis strip 300 , and the reaction unit ( ) of the test window 130 and the third pad 330 of the upper case 100 . 332 ) and the control unit 334 may be combined with the lower case 200 at a position corresponding to the position.
  • the one or more flow rate adjusting units 110 formed in the upper case 100 are formed at a position for pressing the second pad 320 , and the present invention is not limited thereto.
  • reaction unit 332 and the control unit 334 of the third pad 330 are combined so that a user using the diagnostic kit 10 can visually check through the test window 130 , and the reaction unit 332 and If the control unit 334 is coupled at a position where it cannot be confirmed, it may be regarded as defective.
  • the reaction unit 332 is shown to be in contact with the analysis target sample 312 before the control unit 334, but is not necessarily limited thereto, and the control unit 334 is the reaction unit. It may be formed to come into contact with the sample to be analyzed 312 before 332 .
  • FIG. 10 is a view showing a portion in contact with the analysis strip at least one flow rate control unit located in the upper case according to an embodiment of the present invention.
  • the one or more flow rate control units 110 may apply pressure to the pressure region where the at least one flow rate control unit 110 contacts the analysis strip 300 .
  • the pressing region includes a first pressing region 113 , a second pressing region 115 , and a third pressing region 117 .
  • the pressing region may omit some of the various components exemplarily illustrated in FIG. 10 or may additionally include other components.
  • the pressing region may be formed in at least one of the second pad 320 , the third pad 330 , or between the second pad 320 and the third pad 330 .
  • the first pressing region 113 is formed on the second pad 320 , and one or more flow rate adjusting units 110 are in contact with the second pad 320 at the upper end of the second pad 320 .
  • the second pressing region 115 is formed between the second pad 320 and the third pad 330 , and at least one flow rate adjusting unit 110 at an upper end between the second pad 320 and the third pad 330 . ) is abutted to apply pressure between the second pad 320 and the third pad 330 .
  • one or more flow rate control units 110 abut at the upper end where the reaction unit 332 and the control unit 334 of the third pad 330 are positioned to apply pressure to the third pad 330 . is the part that adds
  • the pressure applied to the pressurized region is adjusted by the height of the one or more flow rate control units 110 , and the flow rate of the sample to be analyzed 312 is controlled according to the height of the one or more flow rate control units 110 to determine the reaction rate and You can control the accuracy.
  • the ratio of the contact area of the flow rate control unit 110 pressing the first pressing region 113, the second pressing region 115, or the third pressing region 117 is 40% ⁇ 80% is preferred.
  • the ratio of the contact area refers to a ratio between the total area in which the flow rate controllers exist (including the space between the flow rate controllers) and the area of the region where the flow rate controllers are actually present.
  • the area of the pressurized flow rate control unit 110 may be reduced, so that the flow rate of the sample 312 to be analyzed may not be slowed down, and if the ratio of the contact area is higher than 80%, the flow rate There may be a problem that the analysis target sample 312 cannot pass by the control unit 110 .
  • FIG. 11 is a view showing a flow rate control unit including a coating layer according to an embodiment of the present invention.
  • the flow rate control unit 110 includes a coating layer 140 .
  • the coating layer 140 may be a hydrophobic coating layer formed by hydrophobic coating, a hydrophilic coating layer formed by hydrophilic coating, or a coating layer coated by a selective ion permeation membrane.
  • the coating layer 140 may be formed in a shape surrounding the outside of the flow rate control unit 110, but is not necessarily limited thereto.
  • the coating layer 140 is illustrated as being formed on the outside of the flow rate control unit 110 , but is not necessarily limited thereto and is formed only on the lower side of the flow rate control unit 110 , or the flow rate control unit 110 . It may be formed only on a part of the top or bottom of
  • the coating layer 140 may be formed by coating only a portion of the plurality of flow rate control units 110 , and may not be a coating layer formed by the same material as the plurality of flow rate control units 110 .
  • some coating layers 140 formed on the plurality of flow rate control units 110 may be hydrophilic coating layers, and some coating layers 140 may be hydrophobic coating layers.
  • FIG. 12 is a view showing one or more flow rate control unit treated with hydrophobic / hydrophilic according to an embodiment of the present invention.
  • the one or more flow rate control units 110 may include a first flow rate control unit 112 and a second flow rate control unit 114 .
  • the first flow rate control unit 112 includes a hydrophobic coating layer formed by a hydrophobic coating.
  • the second flow rate control unit 114 includes a hydrophilic coating layer formed by the hydrophilic coating.
  • the sample to be analyzed 312 avoids the first flow rate control unit 112 and moves in a direction in which the second flow rate control unit 114 is positioned, and may be temporarily concentrated or mixed. Through this, the reactivity of the diagnostic kit 10 may be improved.
  • the one or more flow rate control units 110 may perform hydrophilic coating through a plasma treatment method or a hydrophilic silane coating method using a gas forming a hydrophilic gas.
  • Gas forming the hydrophilic gas may include O 2 , CO 2 , H 2 O 2 , and the like.
  • the gas forming the hydrophilic gas may be oxygen (Oxygen).
  • the one or more flow rate control units 110 may perform hydrophobic coating through at least one of a plasma treatment method through a gas forming a hydrophobic gas, a hydrophobic silane coating method, or a Teflon coating method. have.
  • the gas forming the hydrophobic gas may include CF 4 , SF 6 , C 3 F 6 , and the like.
  • the oxygen plasma treatment method, the silane coating method, or the Teflon coating method is an ionized state in which the density of ions and electrons is approximately the same, and the first flow rate control unit 112 second flow rate control A portion 114 may be formed.
  • the coating method for forming the hydrophilic coating layer and the hydrophobic coating layer on the surface of the flow rate control unit 110 is not necessarily limited to the above-described method.
  • the diagnostic kit 10 includes one first flow rate control unit 112 and two second flow rate control units 114 .
  • the plurality of nanoparticles 322 may move avoiding the first flow rate control unit 112 , and may diffuse through the second flow rate control unit 114 side. Through this, the nanoparticles move toward the second flow rate controller 114 and may be temporarily concentrated, and mixing may occur to improve the reactivity of the analyte sample 312 .
  • mixing may be mixing nanoparticles.
  • the diagnostic kit 10 is configured to interfere with the flow of fluid through the hydrophobic coating layer and the hydrophilic coating layer coated on the one or more flow rate control units 110, thereby improving the sensitivity. .
  • FIG. 13 is a view showing one or more flow rate controllers coated with a selective ion exchange material according to an embodiment of the present invention.
  • the one or more flow rate control units 110 may include a third flow rate control unit 116 and a fourth flow rate control unit 118 .
  • the third flow rate control unit 116 may include a selective ion permeable membrane coating layer coated with a selective ion permeable membrane.
  • the selective ion permeable membrane coating layer coated with the selective ion permeable membrane may be coated by Nafion.
  • the fourth flow rate control unit 118 may include an electrode coating layer formed of an electrode.
  • the fourth flow rate control unit 118 including an electrode coating layer formed of an electrode may be a general flow rate control unit 110 .
  • the selective ion permeable membrane for selecting, separating, and concentrating a sample is at least one of Nafion, Polystyrene Sulfonate (PSS), or Polyallylamine Hydrochloride (PAH), etc. It may be implemented including one.
  • the selective ion-permeable membrane coating layer coated by the selective ion-permeable membrane serves as a kind of nano-filter that selects and transmits protons.
  • the selective ion permeation membrane is Nafion
  • it allows H+ ions to be selectively and rapidly permeated by hopping and vehicle mechanism due to SO3- in the chemical structure of Nafion. Therefore, through a selective ion-permeable material such as Nafion, the ion-permeable membrane coating layer can substantially function as a nano-filter, and protein materials to be analyzed can be efficiently concentrated in a specific area of the nano-filter in a very short time.
  • the selective ion permeable membrane may generate an ion concentration polarization (ICP) phenomenon by an electric field.
  • ICP ion concentration polarization
  • the diagnostic kit 10 may control the reaction time of the analyte sample 312 by concentrating the analyte sample 312 by ion concentration polarization or controlling the flow of the analyte target sample 312 .
  • the sample to be analyzed 312 is concentrated without passing between the third flow rate control unit 116 and the fourth flow rate control unit 118 in a state where the electric field is applied, and the third flow rate in the state where the electric field is blocked As it moves past the control unit 116 , the flow may be controlled.
  • the third flow rate control unit 116 may serve as a kind of nano-filter that selects and transmits protons.
  • the selective ion permeation membrane is Nafion
  • ions can be selectively and rapidly permeated by a hopping and vehicle mechanism.
  • the analysis target sample 312 to be analyzed can be efficiently concentrated in a very fast time in the analysis strip 300 by the third flow rate control unit 116 through a selective ion permeable material such as Nafion.
  • FIG. 13 (a) is a view showing a state in which an electric field is applied (On) in a diagnostic kit including a flow rate controller coated with a selective ion permeable membrane according to an embodiment of the present invention; (b) is a diagram showing a state in which the electric field is cut off in the diagnostic kit including the flow rate controller coated with the selective ion permeable membrane according to an embodiment of the present invention.
  • the diagnostic kit 10 includes a flow rate control unit 110 including one third flow rate control unit 116 and two fourth flow rate control units 118 in the upper case 100 . do.
  • the plurality of antigens 312 and the plurality of nanoparticles 314 do not diffuse beyond the third flow rate controller 116 in a state in which an electric field is applied (On), and the electric field is blocked. (Off) It may spread beyond the third flow rate control unit 116 .
  • the plurality of analysis target samples 312 and the plurality of nanoparticles 314 diffused beyond the third flow rate controller 116 are one nanoparticle 314 coupled to one analysis target sample 312 . state can spread.
  • the sample to be analyzed 312 may be an antigen, but is not limited thereto.
  • the nanoparticles 314 may be an antibody, but is not limited thereto.
  • an electroosmosis flow may be controlled through the third flow rate control unit 116 .
  • the diagnostic kit 10 may adjust the electric field by fixing the fourth flow rate adjusting unit 118 and adjusting the position at which the third flow rate adjusting unit 116 is fixed.
  • the diagnostic kit 10 may adjust the electric field by fixing the fourth flow rate adjusting unit 118 and adjusting the position at which the third flow rate adjusting unit 116 is fixed.
  • the concentration rate may have a limit due to the limit of the concentration amount. Accordingly, it may be necessary to adjust the optimum concentration according to the adjustment of the interval between the third flow rate control unit 116 and the fourth flow rate control unit 118 .
  • the diagnostic kit 10 coats one or more flow rate control units 110 with a selective ion permeable membrane including Nafion, and then performs local ion concentration polarization (ICP). By forming a phenomenon, the concentration can be increased or the reactivity can be enhanced.
  • ICP local ion concentration polarization
  • the first flow rate adjusting unit 112 may include a first protrusion at the lower end
  • the second flow rate adjusting unit 114 may include a second protrusion at the lower end.
  • the first protrusion and the second protrusion may be formed in the shape shown in FIG. 3 , but are not limited thereto.
  • the first protrusion and the second protrusion may be coated with a selective ion permeable membrane coating layer or an electrode coating layer.
  • the third flow rate control unit 116 may include a third protrusion at the lower end
  • the fourth flow rate control unit 118 may include a fourth protrusion at the lower end. 1st projection.
  • the second protrusion, the third protrusion, and the fourth protrusion may be formed in the shape shown in FIG. 3 , but are not limited thereto. Specifically, the first projection.
  • the second protrusion, the third protrusion and the fourth protrusion may be coated with a hydrophilic coating layer, a hydrophobic coating layer, a selective ion permeable membrane coating layer, or an electrode coating layer.
  • the first flow rate control unit 112 may include a hydrophobic coating layer and a selective ion permeable membrane coating layer
  • the second flow rate control unit 114 may include a hydrophilic coating layer and an electrode coating layer.
  • A shows a diagnostic kit including the flow rate control unit 110 forming the plurality of protrusions 111 shown in FIG. 4
  • B represents a diagnostic kit including the flow rate control unit 110
  • C represents a general diagnostic kit indicates
  • Intensity indicates a degree to which the analysis strip 300 is pressed, and may mean a pressure applied to the analysis strip 300 .
  • the diagnostic kit including the flow rate adjusting unit 110 forming the plurality of protrusions 111 has higher sensitivity and limit of detection than the diagnostic kit including the flow rate adjusting unit 110 .
  • LOD is high.
  • the diagnostic kit including the flow rate controller 110 has higher sensitivity and limit of detection (LOD) than a general diagnostic kit.
  • the diagnostic kit including the flow rate controller 110 that forms a plurality of protrusions 111 over time exhibits the highest intensity, and the higher the intensity, the higher the sensitivity and detection. It can be seen that the Limit of Detection (LOD) increases.
  • LOD Limit of Detection
  • 15 is a graph for observing the reaction results of the diagnostic kit according to the concentration in various embodiments of the present invention.
  • A shows a diagnostic kit including the flow rate control unit 110 forming the plurality of protrusions 111 shown in FIG. 4
  • B represents a diagnostic kit including the flow rate control unit 110
  • C represents a general diagnostic kit indicates
  • 15 may show the signal intensity (Color Intensity) according to the concentrations of A, B, and C in an embodiment of the present invention.
  • the concentration means the concentration of the sample to be analyzed 312, and when pressure is applied to the analysis strip 300 through the plurality of protrusions 111 or the flow rate controller 110, the sample to be analyzed 312 is concentrated and the concentration is increased. can increase
  • the signal intensity indicates the degree to which the signal is diffused in the analysis strip 300 and displayed on the reaction unit 332 and the control unit 334 of the third pad 330 according to the reaction result.
  • the diagnostic kit including the flow rate control unit 110 forming the plurality of protrusions 111 has a higher signal intensity than the diagnostic kit including the flow rate control unit 110 .
  • the diagnostic kit including the flow rate controller 110 has a higher signal intensity (Color Intensity) than a general diagnostic kit.
  • the diagnostic kit including the flow rate controller 110 that forms a plurality of protrusions 111 over time shows the highest signal intensity (Color Intensity) as the concentration of the sample 312 to be analyzed increases. can be checked
  • 16 is a diagram illustrating false positives of an influenza test (Influenza kit) according to the concentration of a surfactant in an embodiment of the present invention.
  • the Extraction Buffer used in the LFA (Lateral Flow Assay) kit contains a surfactant, but as the concentration of the surfactant increases, the occurrence of Ion Concentration Polarization (ICP) becomes weaker. , false positives are less likely to appear.
  • ICP Ion Concentration Polarization
  • the concentration of surfactant for the buffer to be applied to the LFA kit can be confirmed depending on the concentration of surfactant for the buffer to be applied to the LFA kit.
  • concentration of surfactant in tween-20 used in the LFA kit can be used at 0.05% ⁇ have.
  • the concentration of the surfactant used in the diagnostic kit increases as the degree of occurrence of ion concentration polarization (ICP) is controlled using the flow rate controller 110, the ion concentration polarization (Ion Concentration) Polarization (ICP) is less likely to occur and false positives are less likely to appear.
  • ICP ion concentration polarization

Landscapes

  • Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Urology & Nephrology (AREA)
  • Analytical Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Cell Biology (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Automatic Analysis And Handling Materials Therefor (AREA)

Abstract

L'invention concerne un kit de diagnostic comprenant : une entrée à travers laquelle est introduit un échantillon à analyser ; un boîtier supérieur comprenant au moins une unité de régulation de débit destinée à réguler le débit de l'échantillon à analyser en cours d'introduction ; un boîtier inférieur destiné à être assemblé avec le boîtier supérieur afin de lui correspondre ; et une bande d'analyse fixée sur le boîtier inférieur et destinée à afficher des résultats de réaction en fonction de la diffusion de l'échantillon à analyser dans l'état dans lequel au moins une partie de la bande d'analyse est mise sous pression par ladite unité de régulation de débit au moins.
PCT/KR2021/001882 2020-02-14 2021-02-15 Boîtier supérieur comprenant une unité de régulation de débit, et kit de diagnostic sur site le comprenant WO2021162508A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR1020200018582A KR102461334B1 (ko) 2020-02-14 2020-02-14 유속 조절부를 구비하는 상부 케이스 및 이를 구비한 현장용 진단 키트
KR10-2020-0018582 2020-02-14

Publications (1)

Publication Number Publication Date
WO2021162508A1 true WO2021162508A1 (fr) 2021-08-19

Family

ID=77292461

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/KR2021/001882 WO2021162508A1 (fr) 2020-02-14 2021-02-15 Boîtier supérieur comprenant une unité de régulation de débit, et kit de diagnostic sur site le comprenant

Country Status (2)

Country Link
KR (1) KR102461334B1 (fr)
WO (1) WO2021162508A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR100506165B1 (ko) * 2005-02-02 2005-08-05 주식회사 에스디 비연속식 면역분석장치 및 이를 이용한 면역분석방법
KR20150095137A (ko) * 2014-02-12 2015-08-20 광운대학교 산학협력단 마이크로 유체 기반 표면전하 제어형 단백질 농축 소자 및 그 제조 방법
KR20180005090A (ko) * 2016-07-05 2018-01-15 에이디텍 주식회사 분석 시료의 검출을 위한 랩온어 칩 및 이의 제조방법
US20190329246A1 (en) * 2016-06-14 2019-10-31 Denka Company Limited Membrane Carrier for Liquid Sample Test Kit, Liquid Sample Test Kit, and Method for Producing Liquid Sample Test Kit
KR20190124907A (ko) * 2018-04-27 2019-11-06 서강대학교산학협력단 면역 화학 진단법을 이용한 표적 항원 검출용 종이기반 3차원 구조의 미세칩과 이를 이용한 표적항원 검출 방법

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR100506165B1 (ko) * 2005-02-02 2005-08-05 주식회사 에스디 비연속식 면역분석장치 및 이를 이용한 면역분석방법
KR20150095137A (ko) * 2014-02-12 2015-08-20 광운대학교 산학협력단 마이크로 유체 기반 표면전하 제어형 단백질 농축 소자 및 그 제조 방법
US20190329246A1 (en) * 2016-06-14 2019-10-31 Denka Company Limited Membrane Carrier for Liquid Sample Test Kit, Liquid Sample Test Kit, and Method for Producing Liquid Sample Test Kit
KR20180005090A (ko) * 2016-07-05 2018-01-15 에이디텍 주식회사 분석 시료의 검출을 위한 랩온어 칩 및 이의 제조방법
KR20190124907A (ko) * 2018-04-27 2019-11-06 서강대학교산학협력단 면역 화학 진단법을 이용한 표적 항원 검출용 종이기반 3차원 구조의 미세칩과 이를 이용한 표적항원 검출 방법

Also Published As

Publication number Publication date
KR20210103869A (ko) 2021-08-24
KR102461334B1 (ko) 2022-10-28

Similar Documents

Publication Publication Date Title
WO2014181980A1 (fr) Bandelette immunochromatographique susceptible d'éviter un effet prozone et trousse la comprenant
WO2014196803A1 (fr) Bandelette de test rapide munie d'une ligne de contrôle variable et kit de diagnostic utilisant celle-ci
WO2014010927A1 (fr) Structure microfluidique, dispositif microfluidique ayant celle-ci et procédé de commande de dispositif microfluidique
WO2021162508A1 (fr) Boîtier supérieur comprenant une unité de régulation de débit, et kit de diagnostic sur site le comprenant
WO2017039356A1 (fr) Appareil de détection d'allergènes à l'aide d'un procédé de détection électrochimique
WO2009145532A2 (fr) Appareil multi-canaux pour la mise en évidence de protéines bidimensionnelle a base de produits sans gel
WO2019208961A1 (fr) Micropuce à structure 3d à base de papier pour détecter un antigène cible à l'aide d'un dosage immunochimique, et procédé de détection d'antigène cible à l'aide de celle-ci
WO2019107763A1 (fr) Dispositif microfluidique capable d'éliminer des microbulles dans un canal en utilisant un film mince poreux, dispositif d'injection d'échantillon pour prévenir l'afflux de bulles, et procédé de liaison d'un panneau d'élément microfluidique à l'aide d'un film de démoulage
WO2018084337A1 (fr) Procédé de mesure du ratio d'hémoglobine glyquée
WO2018182082A1 (fr) Focalisation isoélectrique basée sur une puce microfluidique fondée sur une détection de conductivité sans contact et ne nécessitant aucune pompe
WO2011111908A1 (fr) Appareil collectant et récupérant sélectivement des particules fines
WO2020235964A1 (fr) Appareil de diagnostic pour immunoessai
WO2020197196A1 (fr) Dispositif de dosage immunologique et procédé de dosage immunologique
WO2019013530A2 (fr) Kit, méthode et appareil de diagnostic
WO2012173342A1 (fr) Échantillonneur
WO2022119086A1 (fr) Biocapteur de type patch
WO2017131270A1 (fr) Procédé de criblage d'inhibiteur d'interaction protéine-protéine utilisant un nanopore
WO2022039583A1 (fr) Puce pour le dosage d'échantillon et procédé de dosage d'échantillon utilisant une puce pour le dosage d'échantillon
WO2021020910A1 (fr) Dispositif d'analyse simultanée de multiples biomarqueurs et procédé d'analyse simultanée de multiples biomarqueurs
WO2024147538A1 (fr) Dispositif d'analyse ayant une fonction de correction de la concentration d'analyte en fonction du taux d'hématocrite d'un échantillon de sang total
WO2024080388A1 (fr) Biocapteur
WO2018080234A1 (fr) Bouton de commutation et module de fonctionnement le comprenant
WO2023120913A1 (fr) Dispositif de détection rapide et très sensible d'agents pathogènes et méthode d'analyse d'agents pathogènes utilisant ce dispositif
WO2023282728A1 (fr) Agents de blocage lipidiques pour la détection d'analytes
WO2020055133A1 (fr) Unité d'interface

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 21753009

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 21753009

Country of ref document: EP

Kind code of ref document: A1